6th Human Factors & User Experience for Medical Device Design  

18-19 September 2019  | Minneapolis, USA

Darin S. Oppenheimer

Executive Director, GRACS Device & Digital Health

"Streamlining Device Development to Enhance Medical Device Innovation."

Drew Seils

Principal Human Factors Design Engineer

"Organizing Implementation of Human Factors in Design Control for Effective Development of Medical Devices"

" Creating Better Alignment and Collaboration between Teams to Promote a Successful Product Development Process"

User Experience and Human Factors Engineer
Becton Dickinson 

Brittany Williams

 For registration details and multiple attendee discounts, please contact:

Melini Hadjitheori 

Tina Rees, Ph.D.

Associate Director- Human Factors
Ferring Pharmaceuticals

"Exploring Rigorous Recruitment Methods to Improve Human Factors."

We brought together key industry leaders  from medical device and life science firms that have devoted their time and energy into human factors and user experience for Medical Device design. 

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 You will be presenting on “Leveraging Human Factors Earlier in the Product Development Process to Ensure Successful Approval,” what are some key takeaways the attendees can expect from your session? 

I’m really hoping that people will learn some strategies for utilizing human factors prior to summative testing. Summative testing is often seen as the holy grail; the point where you learn whether your human factors process passes or fails. I hope my presentation will challenge that convention and demonstrates that human factors can and should be used in every development phase, from early concept ideation to requirements development and prototype design. If you have an established human factors process from the beginning, the summative test will serve not as a final exam, but as an opportunity to demonstrate what you learned along the way. 

Which practices can be best utilized to improve the design and development process? 

Human factors often serves as a link between different technical functions involved in medical device design, making interdisciplinary collaboration critically important. One of the ways to incorporate human factors earlier in the process is to learn about the various functions that you can work with. By establishing collaborations, there’s a greater opportunity for others to learn what human factors can offer, resulting in a greater acceptance of human factors earlier in the design process.   

How is it beneficial to conduct early formative testing? 

Early formative testing can be a major factor in saving time and money on a project. If early formative testing is not performed, you run the risk of discovering issues late in the design process, requiring anything from minor design changes to complete redesigns. Even minor usability issues that lead to small design changes can require new testing to be performed by multiple development teams, adding time and cost. Conducting formative testing throughout the design process also increases the potential for successful summative testing, allowing any issues to be identified and addressed earlier in the process. 

Why is it important to embrace usability testing in the beginning rather than at the end? 

Usability testing performed at the beginning of the design process allows you to investigate both positive and negative aspects of design choices and can provide data to support those decisions. By conducting early testing, you can make informed decisions and avoid issues further down the road. Development teams can run the risk of assuming they know what is best for the device user; usability testing provides a method to test those assumptions. 

In your experience, what are the best strategies when analyzing study results? 

The type of analysis needed for your study almost always depends on the purpose of the testing. If you’re comparing one design or approach against another, you may need to analyze the results in a way that lets you determine statistical significance. On the other hand, if you’re concerned with user error leading to potential harm, a single data point can be meaningful even if it’s not statistically significant. One of the most important aspects of analyzing study results is to plan how you are going to analyze the results BEFORE you design the study. Ask what you’re trying to learn from the study and what type of analyses you would need to perform to inform that learning. That will inform the methodology you should use and help guide your study design. 

What key drivers motivated you to attend this conference? What do you hope to gain? 

I have had colleagues that attended this conference previously and spoke very highly of what they learned. Human factors is a rather young scientific field and a small discipline compared to most others, so any opportunity to network and learn from others is extremely helpful. I am hoping to gain a broader appreciation of what others in the field are working on and to learn new methods of tackling the challenges that are common across human factors. 

Ahead of the 6th Human Factors & User Experience for Medical Device Design, we spoke with Dr. Jeremy Schwark, Ph.D.
Staff Human Factors Engineer at Abbott about leveraging Human Factors in the Product Development Process.


Dr. Jeremy Schwark, will be presenting during the first day, 18th of September at  9:00am.
Presentation topic: Leveraging Human Factors Earlier in the Product Development Process to Ensure Successful Approval

• Incorporating human factors early for advantages in design instead of making changes last minute to pass validations
• Embracing usability testing in the beginning rather than at the end to identify issues and make improvements
• Conducting early formative testing to save time, money and effort in the product development cycle
• Analyzing study results to reveal whether a device has effectively addressed user’s needs